Hetero gets emergency nod for Tocilizumab use
Drug firm Hetero on Monday said it has received emergency use authorisation from Drug Controller General of India (DCGI) for its biosimilar version of Tocilizumab for treatment of Covid-19 in hospitalised adults.
The company will market the drug under the brand name ‘Tocira’, Hetero said in a statement.
This authorisation will enable medical practitioners to use the drug for the treatment of Covid-19 in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation, it added.
“This approval is extremely crucial for supply security in India considering a global shortage of Tocilizumab. We will be working closely with the government to ensure equitable distribution,” Hetero Group chairman, B Partha Saradhi Reddy said.
“We are pleased with the approval of Hetero’s Toilizumab. This demonstrates our technical capabilities and commitment towards bringing important therapeutics relevant to Covid-19 care. We will work closely with the government to ensure equilabs table distribution,” Dr Reddy noted. Tocira will be marketed by Hetero’s associate company Hetero Healthcare in India.
Hetero’s biologics arm, Hetero Biopharma will manufacture the drug at its dedicated biologics facility, based at Jadcherla in Hyderabad, the statement said.
The company’s Tocilizumab 400mg/20ml is the biosimilar version of Roche’s Actemra/ Roactemra, and will be available from September-end, it added.
Hetero is among several Hyderabad-based companies which are involved in India’s fight against the contagious disease, Bharat Biotech International Limited and Dr Reddy’s being the other two. It is engaged in research and development, manufacturing and marketing of chemical and biologic medicines. It is a among the largest producers globally of active pharmaceutical ingredients (API).
Earlier, it was reported Hetero Drugs, through its biologics arm, will be producing “over” 100 million doses of Russian Covid-19 vaccine Sputnik V starting 2021, said the Russian Direct Investment Fund (RDIF).
The firm, through subsidiary Hetero Biopharma, is expected to produce these doses over the course of the year, according to RDIF. The vaccines produced here may also be used to fulfill demand from other countries.
Sputnik V is also expected to be tested in mid- to late-stage clinical trials in India by Dr Reddy’s Laboratories, another drugmaker.
According to the latest interim analysis of data collected from participants undergoing Sputnik V trials in Russia, the vaccine seems to have demonstrated an efficacy of 91.4%.
“Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’S international partners in India, Brazil, China, and other countries,” stated RDIF in a release.